Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone Undecanoate | Experimental | Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone undecanoate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum T Concentration at Steady State | Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment. | pre-dose on Days 1, 3, 5, 6, and 7 |
| Serum T Concentration at Steady-State | Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment. | pre-dose on Days 10, 14, 17, 21, 24, 27, and 28 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory Flippo, MD | Alabama Clinical Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21474786 | Derived | Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Undecanoate | Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Undecanoate | Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum T Concentration at Steady State | Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment. | All participants were included in the analysis population | Posted | Least Squares Mean | Standard Error | ng/dL | pre-dose on Days 1, 3, 5, 6, and 7 |
|
|
2 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone Undecanoate | Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Belching | Gastrointestinal disorders | MeDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert E. Dudley, PhD, CEO and President | Clarus Therapeutics, Inc. | 847-562-4300 | rdudley@clarustherapeutics.com |
Not provided
| ID | Term |
|---|---|
| D005058 | Eunuchism |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Serum T Concentration at Steady-State | Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment. | All participants were included in the analysis population | Posted | Least Squares Mean | Standard Error | ng/dL | pre-dose on Days 10, 14, 17, 21, 24, 27, and 28 |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 6 |
| 15 |
| Gout Flareup | Metabolism and nutrition disorders | MeDRA | Systematic Assessment |
|
| Irritabililty | General disorders | MeDRA | Systematic Assessment |
|
| Lower Extremity Edema | General disorders | MeDRA | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | MeDRA | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MeDRA | Systematic Assessment |
|
| Sore throat | Infections and infestations | MeDRA | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MeDRA | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MeDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MeDRA | Systematic Assessment |
|
| Worsening sciatica | Nervous system disorders | MeDRA | Systematic Assessment |
|
| Stomach bloating | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MeDRA | Systematic Assessment |
|
Not provided
Not provided